Problems with Composix Kugel hernia mesh allegedly caused an Illinois woman to suffer painful and permanent injuries, which resulted in the need for additional surgery about two years later to remove the hernia patch from her body.

The complaint (PDF) was filed by Vicky Sanders in the U.S. District in the Southern District of Ohio on October 29, indicating that C.R. Bard and its Davol, Inc. subsidiary knew or should have known that the Composix Kugel patch caused an unreasonable risk of harm, yet continued to promote and market the product for use during hernia repair.

Sanders indicates that she was implanted with an 11.4 cm by 11.4 cm Composix Kugel patch in March 2008, during an incisional hernia repair. However, a little over two years later, she developed complications from the hernia mesh, which resulted in the need for additional revision surgery in July 2010.

During the revision surgery, the surgeon found dense adhesions between the omentum, bowel, small intestine, and mesh. There was also loosening and separation of the mesh, resulting in recurring hernia.

The lawsuit notes that prior to Sanders’ hernia surgery in March 2008, the manufacturers were aware of defects with the patch and had issued Composix Kugel hernia mesh recalls for several different versions of the product, which were categorized as an FDA Class I recall due to the risk of life-threatening or serious injury associated with the device. The recalls were issued due to a faulty “memory recoil ring” (PET Ring), which can break under pressure, resulting in ring migration, intestinal fistulae, bowel perforation and even death.

“Neither Plaintiff nor her physicians were aware of the defective and dangerous condition of the Composix Kugel or that this unreasonably defective condition was the cause of Plaintiff’s injuries until after the product was removed,” according to the complaint. “Defendants were aware of the high degree of complications and failure rate associated with their Composix Kugel before it was recalled. Defendants were aware of the defect in manufacture and design prior to Plaintiff Sanders’ implantation surgery on March 28, 2008.”

In 2011, C.R. Bard agreed to Composix Kugel mesh settlements that resolved about 2,600 cases. However, the agreement left hundreds of claims unsettled, and individuals with the recalled hernia mesh implanted in their body continue to experience problems when the hernia mesh fails.

Sanders complaint now comes as Bard faces a growing number of new hernia mesh lawsuits, involving dangerous design defects associated with various different products introduced in recent years. All cases filed in the federal court system have been consolidated as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Edmund Sargus in the Southern District of Ohio for coordinated discovery and pretrial proceedings.